← FDA DRUG APPROVALS

FDA NDA · NDA021151

BETAPACE AF

Sponsor: LEGACY

APPLICATION
NDA021151
TYPE
NDA
ORIGINAL APPROVAL
2000-02-22
LATEST ACTION
2011-08-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

BETAPACE AFDiscontinued
SOTALOL HYDROCHLORIDE 40MG · TABLET · ORAL
BETAPACE AF · ReferencePrescription
SOTALOL HYDROCHLORIDE 120MG · TABLET · ORAL
BETAPACE AFDiscontinued
SOTALOL HYDROCHLORIDE 60MG · TABLET · ORAL
BETAPACE AFDiscontinued
SOTALOL HYDROCHLORIDE 100MG · TABLET · ORAL
BETAPACE AF · ReferencePrescription
SOTALOL HYDROCHLORIDE 160MG · TABLET · ORAL
BETAPACE AF · ReferencePrescription
SOTALOL HYDROCHLORIDE 80MG · TABLET · ORAL

Approval history

2011-08-17Labeling · Supplement 10 · unknown — Label ↗AP
2011-02-03Labeling · Supplement 9 · unknown — Letter ↗AP
2003-04-02Manufacturing (CMC) · Supplement 5 · standard — Letter ↗AP
2003-03-14Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2001-10-01Labeling · Supplement 3 · standardAP
2000-11-22Manufacturing (CMC) · Supplement 1 · standardAP
2000-02-22Type 6 - New Indication (no longer used) · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →